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Premarketing Regulation - Safety
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EXPERT VIEW
In praise of the CE marking, but medtech's worst fear is still alive
06 July 2010
Ashley Yeo
The European Medicines Agency review meeting in London on 30 June passed with scarcely a mention of devices and diagnostics. This was perhaps as expected, given that the meeting, held to examine the outcomes of the assessment of Ernst & Young's ...
LATEST FEATURES
Advanced Therapy Medicinal Products in the EU: Navigating the Regulatory Maze
10 March 2010
Ralf D Hess explains the complex regulatory framework that manufacturers need to consider when seeking marketing authorisation of ATMPs in Europe. ...
Toxic Substances in Devices
15 January 2010
Ashley Yeo examines the issues surrounding toxic substances in devices and looks at what the alternatives are. The five-month consultation by the ...
Electronic Cigarettes - Common Concerns but Not Much Regulatory Consensus (Update)
30 November 2009
Peter Charlish looks at the regulation of “e-cigarettes” and finds they can be drugs, devices, neither or both. Unless it is very tightly drawn up, ...
>> More Latest Features...
LATEST COUNTRY PROFILES
Trademarks Briefing (Devices) - Luxembourg
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
Regulation of Medical Devices Briefing - Spain
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Española del Medicamento, the ...
>> More Latest Country Profiles...
MULTIMEDIA
RAJ Devices News Roundup, July 2010
19 July 2010
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